510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,336 records, page 38 of 1187
FDA device recalls, page 38 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1393-2026Class IIMedline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-1392-2026Class IIMedline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1391-2026Class IIMedline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1390-2026Class IIMedline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1389-2026Class IIMedline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1388-2026Class IIMedline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1387-2026Class IIMedline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150CMEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-1386-2026Class IIMedline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-1385-2026Class IIMedline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC...MEDLINE INDUSTRIES, LP - NorthfieldNXA
Z-1384-2026Class IIMedline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1286-2026Class IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1285-2026Class IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1284-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1283-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1282-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1281-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1280-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1279-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1278-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1277-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1276-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1275-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1274-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1273-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1272-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1271-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1270-2026Class IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1269-2026Class IIProduct Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1268-2026Class IIBrand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1318-2026Class IISpectral CT 7500 on Rails; Product Code (REF): 728334;Philips North America LLCJAK
Z-1317-2026Class IISpectral CT; Product Code (REF): 728333;Philips North America LLCJAK
Z-1316-2026Class IIIQon Spectral CT; Product Code (REF): 728332;Philips North America LLCJAK
Z-1315-2026Class IIBrilliance iCT; Product Code (REF): 728306;Philips North America LLCJAK
Z-1337-2026Class IIIWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POMStraumann USA, LLCNDP
Z-1231-2026Class IIPRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without...Baxter Healthcare CorporationMDP
Z-1230-2026Class IIPRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without...Baxter Healthcare CorporationKDI
Z-1229-2026Class IIPRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without...Baxter Healthcare CorporationKDI
Z-1228-2026Class IIPRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without...Baxter Healthcare CorporationKDI
Z-1227-2026Class IIPRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without...Baxter Healthcare CorporationKDI
Z-1226-2026Class IIOXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed...Baxter Healthcare CorporationKDI
Z-1225-2026Class IIPRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or...Baxter Healthcare CorporationKDI
Z-1224-2026Class IIPRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or...Baxter Healthcare CorporationKDI
Z-1435-2026Class IIMeijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE...MEDLINE INDUSTRIES, LP - NorthfieldFRO
Z-1434-2026Class IIMedline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1433-2026Class IIMedline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1432-2026Class IIMedline Convenience Kits: 1) NAIL KIT, Model Number: POD14214MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1431-2026Class IIMedline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9%...MEDLINE INDUSTRIES, LP - NorthfieldFRO
Z-1236-2026Class IIVITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B...bioMerieux, Inc.LTW
Z-1498-2026Class IIRaz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code...Raz Design IncINN
Z-1234-2026Class IIEMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10...Encore Medical, LPLPH